Cleared Traditional

K111934 - PD-100 SERIES ULTRASONIC POCKET DOPPLER

K111934 is an FDA 510(k) clearance for PD-100 SERIES ULTRASONIC POCKET DOPPLER, manufactured by Advanced Instrumentations, Inc.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K111934 · Advanced Instrumentations, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
76d
Days
Class 2
Risk

K111934 is an FDA 510(k) clearance for the PD-100 SERIES ULTRASONIC POCKET DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Advanced Instrumentations, Inc. (Hialeah, US). The FDA issued a Cleared decision on September 22, 2011 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Instrumentations, Inc. devices

FDA 510(k) Submission Details - K111934

510(k) Number K111934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date September 22, 2011
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 33
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K111934.
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015
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K112529 · Advanced Instrumentations, Inc. · Oct 2011
FETAL DOPPLER
K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2011
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087 · Edan Instruments, Inc. · Mar 2008
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc. · May 2004